Understanding of drug development through commercialization and lifecycle management is key to the role, and with that experience working cross-functionally and driving to consensus, willingness to pivot as priorities change, and knowledge and/or experience of manufacturing and supply chain. The position will work with the CMSC, Quality, DTE, and DSS leads within the Vertex Small Molecule and Cell and Gene Therapy teams to build and maintain dashboards and analytics to drive data-driven decision making. This Commercial Manufacturing and Supply Chain (CMSC) Senior Manager, Business Analytics and Reporting (BAR) will be responsible for leading and driving complex cross-functional project teams for the purposes of executing our CMSC supply and manufacturing analytics needs.$106k-133k yearly est.13d ago
Expert / Senior / Medical Writer (Remote
Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees. As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers.$135k-232k yearly2d ago
Clinical Scientist, Principal (Remote
The Clinical Scientist Principal will provide scientific, clinical, and operational input to early and late stage clinical development programs with an emphasis on protocol-specific, in-life clinical data monitoring activities. * Represents Vertex to outside personnel in the development of clinical protocols and study conduct$136k-204k yearly15d ago
Sr. Manager, Cold Chain Logistics Process (Remote Eligible
The Senior Manager of Cold Chain Logistics Process is responsible for leading the development and implementation of processes and procedures to ensure the success of cold chain logistics operations within Vertex Pharmaceuticals This position requires close collaboration with logistics service providers, order management teams, quality assurance, and other stakeholders to ensure adherence to regulatory guidelines and meet business needs.$123k-184.4k yearly15d ago
Director, Regulatory Labeling Strategy (Remote
The Regulatory Labeling Director of global labeling is responsible for leading the labeling strategy and coordinating the development and maintenance of the Target Label Profile (TLP), Company Core Data Sheet (CCDS), and product labeling for major markets across a therapeutic area. At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. 3. Remote and work remotely with occasional travel to Vertex sites for business critical meetings/events.$182k-273.6k yearly4d ago
Principal Data Engineer - Manufacturing Analytics (REMOTE ELIGIBLE
The Principal Data Engineer - Manufacturing Analytics is responsible to enhance efficiencies for the implementation of TIBCO Spotfire and Statistica to make the user experience seamless. At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employe$108k-162k yearly15d ago
Director, Clinical Trial Management (Remote
The Director, Clinical Trial Management is responsible for the planning, oversight, and execution of study and program-level deliverables across a range of study phases within one or more therapeutic areas to ensure corporate goals are met. This role often has responsibility for complex therapeutic areas with multiple compounds under simultaneous clinical development. This role will also manage a high performing global team of Clinical Trial Managers in the fast-paced and expanding Global Clinical Operations (GCO) organization, and may also manage individuals at the Associate Director level who also have program-level responsibilities. This position has a strong affiliation with the GCO Leadership Team and other senior stakeholders within Global Medicines and Development Affairs (GMDA).
Key Duties and Responsibilities:
* Represents GCO as a key Program Team member, responsible for the development and execution of clinical development plans in conjunction with the Program Teams.
* Manages Clinical Trial Managers with responsibility for recruitment, resourcing, training, performance management, employee goal setting and career development. May also manage contract staff.
* Develops operational strategy (study scenario planning, operational decision points and risks, initial study timeline, study financials) for assigned program(s).
* Accountable for operational delivery of all clinical trials within program lifecycle, overseeing cross-functional alignment, budget, and timeline from protocol generation through completion of the clinical study report, ensuring quality and a focus on inspection readiness throughout.
* Proactively identifies study and program risks and implements contingency plans, providing regular updates on study status to GCO Leadership Team and senior stakeholders in GMDA.
* Participates in vendor identification and oversees Clinical Trial Managers in vendor set up and oversight.
* Active involvement in investigator identification and selection, including the expansion to new geographies.
* Provides oversight on the development of study documentation, including clinical trial protocols, study plans and clinical study reports.
* Participates in cross functional study data review where appropriate.
* Develops departmental goals and objectives for Clinical Trial Management.
* Tracks key performance indicators and departmental metrics for Clinical Trial Management and identifies opportunities to optimize processes and procedures (SOPs, Work Instructions).
* Leads cross-functional initiatives
* Serves as representative for Clinical Trial Management on vendor-related Joint Operating Committees.
Knowledge and Skills:
* Demonstration of advanced project/program management skills including timeline and budget management, risk assessment and contingency planning.
* Proven track record of successfully overseeing staff to execute and deliver clinical trials on time and on budget, ensuring inspection readiness throughout.
* Excellent understanding of GCP, CFR and ICH Guidelines.
* Effective team leadership in cross-functional study and program teams, with demonstrated strength in team building.
* Significant experience with direct line management of employees.
* Excellent verbal and written communication skills, organizational skills, problem solving and conflict resolution skills.
* Strong interpersonal skills and demonstrated ability to effectively interface successfully with external parties, including key medical personnel at investigational sites, Key Opinion Leaders, vendors and Patient Advocacy groups.
* Excellent presentation skills with ability to adapt communication and content appropriately based on the intended audience.
* Self-motivated and proactive with ability to work independently in highly time sensitive environment.
* Proficiency in Microsoft Office applications including Microsoft Project, Outlook, Excel, Word and PowerPoint.
Education and Experience:
* Bachelor's degree in life sciences discipline or related discipline
* Typically requires 12 years of experience executing clinical trials globally across all phases of development and 3 years of supervisory/management experience, or the equivalent combination of education and experience.
Pay Range $ 180,000 - 270,000 annually
The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.
At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.
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Company Information
Vertex is a global biotechnology company that invests in scientific innovation.
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com.$180k-270k yearly15d ago
Senior Manager, Strategic Sourcing (Remote
* Manages the Supplier Performance/Relationship Management process that may include Executive Business Reviews that include Senior leaders both within Vertex and with the 3rd party.$127k-168k yearly est.17d ago
Overview: The Vendor Master Specialist role reports to the Accounts Payable Manager, and will be responsible for the onboarding and maintenance of supplier records within the Vertex supplier database. Duties may also include a review of the onboarding process and policy and provide feedback, testing, and backup of Vertex's international team, when necessary, as well as other Accounts Payable tasks. At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations.$52k-78k yearly32d ago
Director Medical Writing (Hybrid
Vertex is an E-Verify Employer in the United States. The Director, Medical Writing Science has responsibility for the management, oversight, operation, and direction of a group within the department as well as independently author critical and complex documents. This position is Boston based with a hybrid schedule of 3 days per week in the office and 2 days remote work. Vertex is a global biotechnology company that invests in scientific innovation. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.$136k-198k yearly est.15d ago
Global Logistics Senior Manager (Remote eligible
They will also be involved with critical logistics projects and solutions that shape the Vertex future or VX-2030 strategy. * Work with various departments such as Pharmaceutical Science, Clinical and Planning teams to ensure proper transactions can be put in place for material creation, movement, and use of Vertex's material. * A Subject matter expert for the Vertex Transportation Management System. Prepares Vertex inventory summaries and works with Audit to resolve discrepancies. The Global Logistics Senior Manager is a fantastic opportunity for a self-starter looking to make an impact on critical products movements to meet patient's needs.$128k-192k yearly15d ago
Regulatory Publishing Manager (Remote
At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey whi The Regulatory Publishing Manager will be responsible for contributing to process improvements for the accurate and quality driven execution of submissions. The Regulatory Publishing Manager is responsible for the creation, assembly, and publishing of electronic submissions and the delivery to global health authorities in an efficient and timely manner. 3. Remote and work remotely with occasional travel to Vertex sites for business critical meetings/events.$168k yearly31d ago
Director, Audit Management, Cell and Gene Therapy (Remote
The Director, Global Compliance Cell and Gene Therapy (CGT), as part of the Global Quality Compliance group within the Vertex Quality Assurance Organization, is responsible for risk based GMP/GDP auditing and compliance programs for CMC CGT platform of products. Vertex is an exciting, fast paced dynamic environment with a strong company culture focused on patients with unmet medical needs. This individual will be responsible for design and execution of risk-based approaches related to the audit of CMC activities, conducted both internal to Vertex and at their respective CDMOs/distributors, assuring adherence to applicable regulations, industry standards, and to Vertex policies, procedures and quality standards as set forth in the Quality Management System. This position leads a team of compliance experts' oversight of key Vertex CMC activities regulated by international regulatory bodies, while continuing to work closely as liaisons with Quality Operations and key business partners globally.$173.6k-260.4k yearly44d ago
Principal Statistical Programmer (Remote
Vertex is a global biotechnology company that invests in scientific innovation. At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. * Provides leadership to ensure compliance with Vertex SOP'S and FDA/ICH/GCP regulations$87k-115k yearly est.39d ago
Principal Manager, Site Activation (Remote
* As a people manager within the organization, may have financial accountabilities and human resource responsibilities for assigned staff. The Principal Manager, Site Activation directly collaborates with the Vertex Clinical Operations Program and Study Leads, Clinical Development, Clinical Budget Team, Quality Assurance, Regulatory, Vendor Management, and Legal Team, as well as Regional Site Advocates and Contract Research Organizations. Furthermore, the Principal Manager, Site Activation will establish long-term relationships with investigative sites, key opinion leaders, institutional review boards as well as patient and trial networks, will work collaboratively with all business partners to communicate decisions, issues, risks and mitigations and will act as an SME for the regional regulatory landscape to drive accelerated Start- Up timelines. The Principal Manager, Site Activation oversees the Study Start-Up portfolio within a dedicated region and therapeutic area, managing the Study Start-Up personnel and acting as a member of the Global Start-Up leadership team.$138.9k-208.3k yearly15d ago
Biostatistical Programming Manager, SDTM Consultant A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. The CDISC Consultant Group (CCG) within Global Statistical Programming helps to align Amgen with changing SDTM CDISC standards and serves as an interface between CDISC and Amgen. Amgen focuses on areas of high unmet medical need and demonstrates its expertise to strive for solutions that improve health outcomes and spectacularly improve people's lives. At Amgen, our shared mission-to serve patients-drives all that we do.$121.8k-135.4k yearly1h ago
Manager, Corporate Affairs, Enterprise Media Relations (US - Remote
This position can sit remotely in the U.S. and does not need to be based in Thousand Oaks, CA. Manager, Corporate Affairs, Enterprise Media Relations This is a unique opportunity to contribute to a hard-working team, harnessing your operational expertise to support Amgen's biggest news. In this role you will be an integral part of Amgen's global media relations team. The Manager, Corporate Affairs, Enterprise Media Relations will play a pivotal role in ensuring the seamless operations of our dynamic media relations team. At Amgen, our shared mission-to serve patients-drives all that we do.$93k-126.4k yearly1h ago
Learning Experience Designer (Remote
The Learning Experience Designer must develop and leverage trusted partnerships with team members, stakeholders, and subject matter experts to ensure speed, quality, and cost effectiveness of the learning they design.$97.7k-153.7k yearly1h ago
Director, Audit Management, Small Molecule (Remote
This individual will be responsible for design and execution of risk-based approaches related to the audit of CMC activities, conducted both internal to Vertex and at their respective CDMOs/distributors, assuring adherence to applicable regulations, industry standards, and to Vertex policies, procedures and quality standards as set forth in the Quality Management System. This Director will provide strategic input and execution of audits and projects, identify and communicate compliance risks, and oversee applicable risk mitigation plans. This position leads a team of compliance experts' oversight of key Vertex CMC activities regulated by international regulatory bodies, while continuing to work closely as liaisons with Quality Operations and key business partners globally. Vertex is an exciting, fast paced dynamic environment with a strong company culture focused on patients with unmet medical needs. The Director, Global Compliance Small Molecule (SM), as part of the Global Quality Compliance group within the Vertex Quality Assurance Organization, is responsible for risk based GMP/GDP auditing and compliance programs for CMC SM platform of products.$173.6k-260.4k yearly44d ago
Senior Associate, Congress Logistics (US - Remote
Senior Associate, Congress Logistics (US - Remote) In this vital role you will assist in the execution of how Amgen approaches Global Congress operations and logistics, both in the in person world as well as hybrid and fully virtual congresses. Transformation: Work with the team to build opportunities for Amgen to centralize its management of Congresses in today's environment. At Amgen, our shared mission-to serve patients-drives all that we do. Operationalize and support existing processes to further Amgen strategy.Operations: Help support and understand the current operations, redefine processes, leading to a seamless operating model going forward for global congresses. ,Strategy: Understanding and capitalizing on the objective of congresses in a virtual and hybrid world will require a pan-congress vision in which One Amgen is front and center.$78k-94.1k yearly1d ago